4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 240 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Ms. Joy L. McElroy 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries"

Good laboratory practices (GLPs) and good manufacturing practices (GMPs)

Description

According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

As per the FDA, GLPS are for non-clinical laboratory studies in which test articles are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals. GLPs are not enforceable by law. They do not include the manufacturing of the product. However, it is important to be able to compare and contrast GLPs with GMPs and understand their requirements.

Join this session, where expert speaker Joy McElroy will compare and contrast between good laboratory practices (GLPs) and good manufacturing practices (GMPs). She will discuss the objective behind GLPs and how they associate with GMPs and SOPs, and the consequences of non-compliance.

Areas Covered

  • Understanding good laboratory practices (GLP)
  • GLP as an FDA regulation
  • Definition of GLPs
  • History of GLPs
  • Why were GLPs created?
  • Objectives of GLPs
  • Mission of GLPs
  • The objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical procedures for data evaluation
  • Instrumentation validation
  • Analytical and laboratory certification
  • Documentation and maintenance of records
  • Consequences of noncompliance
  • Grounds for disqualification
  • Reinstatement of a disqualified facility
  • References

Who will Benefit

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Validation Teams
  • Project Managers
  • Engineering Departments
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Laboratory Personnel

Industries who can attend

This 240-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Joy McElroy

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. 

With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. 

Upon earning a degree in Zoology at North Carolina State University, She made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Ma

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